VP/Global Head, Drug Safety: Stable, growing Biopharma – Central NJ: RETAINED SEARCH

Cornerstone Search Group
December 8, 2021
Greater New York City Area, United States of America
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VP/Global Head, Drug Safety: Stable, growing Biopharma – Central NJ: RETAINED SEARCH

SUMMARY:  Cornerstone has been retained by a very stable and growing Biopharma.  They are looking to hire a newly created position for a Vice President/Global Head of Drug Safety & Pharmacovigilance.  You will have complete ownership of the Drug Safety/PV function to include strategy, operations, risk management, signal detections, and growing a team.  Our client offers a “best of both worlds” working environment.  They operate in a nimble and creative work environment with an exceptional culture which is exemplified by the incredible tenure of their employees.  While operating like a smaller company without the typical larger company obstacles, they are also extremely stable to include a marketed product (cardiovascular/metabolic focus) and a strong appetite for further growth.

POSITION:  Vice President, Global Drug Safety & Pharmacovigilance

LOCATION: Our client is located in an ideal part of Central NJ that allows for candidates to commute from Northern, Southern and Central NJ as well as Eastern PA.


  • Company Culture/Environment: People genuinely like to work here, and they stay. The tenure of their employees is well above industry average.  They offer a culture and environment that is highly collaborative, trusting and forward-thinking.
  • Visibility: A challenging, highly-visible role where you will work alongside of C-level Executives. You will work very closely with and report directly to the CSO who is hands-on and highly respected within Industry.
  • Marketed Product: Our client already has a marketed product with an appetite for further growth and development. This is not a typical high-risk Biotech focused solely on Clinical Development without revenue coming in.
  • Growth Potential: This company is looking to continue to grow both as a whole and within the Drug Safety & Pharmacovigilance.


  • Serve in a critical role safeguarding the health of patients who are administered ’s product(s) through the oversight of the collecting, evaluating, reporting and collating of adverse events.
  • Ensure compliance with internal as well as external global regulatory and safety requirements.
  • Implement a scientifically valid early alert system to proactively discover trends and issues to provide company management with a global view of product safety.
  • Lead the design, implementation and management of applicable Risk Evaluation and Mitigation Strategies (REMS).
  • Define the strategic Pharmacovigilance and REMS plans and policies consistent with company and Global Regulatory Authorities and ensure a compliant global PV system including a PV Auditing Department and PV Compliance Department.
  • Evaluate and implement outsourcing or in-house staff strategy, in collaboration with Medical Affairs, R&D, Regulatory, and other functions, on a continuous basis to optimize Pharmacovigilance capabilities for effectiveness, efficiency, and patient focus.
  • Oversee the medical review, analysis and guidance during the case handling and reporting cycle of Adverse Event reports.
  • Medical evaluation of all other relevant safety information across clinical trials, scientific literature, and non-clinical studies for on-going surveillance and signal detection.
  • Ensure compliance worldwide with applicable regulatory requirements related to Pharmacovigilance and REMS.
  • Provide medical expertise on the safety profile and appropriate risk minimization measures to risk management plans.
  • Identify and evaluate safety signals.
  • Prepare responses to regulatory agency inquiries regarding product safety, benefit-risk relations and risk management.
  • Organize and lead safety related audit inspections globally.
  • Chair the Safety Committee [a multi-functional group (Medical, Marketing, R&D, Regulatory Affairs., Manufacturing, Legal, etc.)], to discuss signals from safety data collected from various channels.


  • 10+ years of Drug Safety/Pharmacovigilance experience to include extensive pharmaceutical experience with demonstrated/increasing responsibilities.
  • MD degree is required at the VP level. They will consider a PharmD or PhD at the ED level.
  • Strong leadership experience to include managing a team as well as cross-functional relationships.


Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted/shared with us as confidential information.  Any information provided/shared with us will not be shared with any parties outside of Cornerstone Search Group without your prior permission.


Thomas Fascia | Partner

E: tfascia@cornerstonesg.com

P: 973-656-0220 x717

LinkedIn: https://www.linkedin.com/in/thomasfascia

CORNERSTONE SEARCH GROUP – Pharma & Biotech Executive Search

PO Box 5657 | Parsippany, New Jersey 07054 USA


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